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NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the Treatment of Resectable, Borderline Resectable, or Locally-Advanced Unresectable Pancreatic Cancer
This phase II trial evaluates whether early switching from modified fluorouracil/irinotecan/leucovorin/oxaliplatin (mFOLFIRINOX) chemotherapy regimen to a combination of gemcitabine and nab-paclitaxel (GA) before surgery is effective in treating patients with pancreatic cancer that can be surgically removed (resectable or borderline resectable), or that has spread to nearby tissue or lymph nodes and cannot be removed by surgery (locally-advanced unresectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, oxaliplatin, gemcitabine, and nab-paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The study will also evaluate the drug losartan in combination with mFOLFIRINOX or GA.
Details
| Lead sponsor | OHSU Knight Cancer Institute |
|---|---|
| Phase | PHASE2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 42 |
| Start date | Thu May 27 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Jan 05 2027 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Pancreatic Adenocarcinoma
- Stage 0 Pancreatic Cancer American Joint Committee on Cancer v8
- Stage I Pancreatic Cancer American Joint Committee on Cancer v8
- Stage III Pancreatic Cancer American Joint Committee on Cancer v8
- Stage IV Pancreatic Cancer American Joint Committee on Cancer v8
Interventions
- Capecitabine
- Fluorouracil
- Irinotecan Hydrochloride
- Leucovorin Calcium
- Losartan Potassium
- Oxaliplatin
- Radiation Therapy
- Resection
- Diagnostic Imaging
- Biospecimen Collection
Countries
United States